Browse Device Recalls
4,686 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 4,686 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 4,686 FDA device recalls in CA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 22, 2017 | The Medtronic StrataMR adjustable valves and shunts are designed to provide c... | Incorrect valve rotor orientation due to misalignment and/or off-center positioning of the Strata... | Class I | Medtronic Neurosurgery |
| Feb 20, 2017 | MaxGuard Extension Set, Model No. ME2064, MP9009C, MP9209, MP9254C The MaxGu... | CareFusion is recalling the MaxGuard Extension Set due to reports of leaks occurring with the 0.... | Class II | CareFusion 303, Inc. |
| Feb 20, 2017 | MaxGuard Extension Set with Injection Site and 0.2 micron filter, Model No. M... | CareFusion is recalling the MaxGuard Extension Set with Injection Site and 0.2 micron filter beca... | Class II | CareFusion 303, Inc. |
| Feb 15, 2017 | Legionella IFA (IF0950) intended for qualitatively detecting and semi-quantit... | After a submission for CLIA database update from Focus Diagnostics to DiaSorin Molecular,the comp... | Class II | Focus Diagnostics Inc |
| Feb 15, 2017 | Legionella IFA Substrate Slide (IF0951) intended for qualitatively detecting ... | After a submission for CLIA database update from Focus Diagnostics to DiaSorin Molecular,the comp... | Class II | Focus Diagnostics Inc |
| Feb 13, 2017 | Beckman Coulter Chemistry Analyzer AU680/AU5800, Catalog No. MU907400 (Rack I... | Beckman Coulter is recalling the Rack ID Labels because the Rack ID number displayed and the Rack... | Class II | Beckman Coulter Inc. |
| Feb 13, 2017 | CELL-DYN Ruby System: List Number: 08H6701; Hematology: The CELL-DYN R... | The Pump Relay Printed Circuit Board Assembly (PCBA) used in the CELL-DYN Ruby instrument may pre... | Class II | Abbott Laboratories |
| Feb 10, 2017 | StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02. The UDI... | Abbott Vascular is recalling the StarClose SE Vascular Closure System because it may exhibit diff... | Class II | Abbott Vascular |
| Feb 8, 2017 | AIA-PACK TgAb CONTROL SET | The label contains two different methodologies. Quality Control values for non-FDA approved metho... | Class III | Tosoh Bioscience, Inc. |
| Feb 8, 2017 | AIA-PACK TPOAb CONTROL SET | The label contains two different methodologies. Quality Control values for non-FDA approved metho... | Class III | Tosoh Bioscience, Inc. |
| Feb 7, 2017 | Raindrop Near Vision Inlay, Model# RD1-1 | ReVision Optics has updated the instructions for use (IFU) for the Raindrop Near Vision Inlay to ... | Class II | Revision Optics Inc |
| Feb 1, 2017 | Final Fit Software Version 1.11 and 1.12; PC Based software installed outsi... | During treatment planning, the procedure was programmed with an unintended (wrong) correction. | Class II | Nidek Inc |
| Feb 1, 2017 | Philips V60 Ventilator with Version 2.20 Software, Description: V 60 Ven... | The V60 Ventilator with Version 2.20 software installed may falsely detect that the blower motor ... | Class II | Respironics California Inc |
| Feb 1, 2017 | Angio WorkStation (XIDF-AWS801) used in conjunction with your Infinix System ... | It was found that during a procedure the Peak Skin Dose (PSD) value displayed by the Dose Trackin... | Class II | Toshiba American Medical Systems Inc |
| Jan 31, 2017 | MiniMed 620G and MiniMed 640G Insulin Pumps with Software Version 2.6 and bel... | Medtronic has identified a software anomaly that can prevent the internal battery of the pump fro... | Class II | Medtronic Inc. |
| Jan 31, 2017 | AngioJet¿ Ultra 5000 A Console:Foot Switch Material number (U PN) 105650 ... | Boston Scientific has received field reports regarding the AngioJet Ultra 5000 A Console foot swi... | Class II | Boston Scientific Corporation |
| Jan 30, 2017 | iChemVELOCITY Urine Chemistry System, Catalog No. 800-3530, 800-7167, 800-771... | The probe misalignment or bending has the potential to lead to delay in reporting results or inco... | Class II | Beckman Coulter Inc. |
| Jan 26, 2017 | The ABL800 Model#:All | Reports that the sample type "cord blood" has been changed into the two sample types "cord blood ... | Class II | Radiometer America Inc |
| Jan 26, 2017 | ABL90 Flex Model #: 393-090 Portable, automated analyzer that measures p... | Reports that the sample type "cord blood" has been changed into the two sample types "cord blood ... | Class II | Radiometer America Inc |
| Jan 25, 2017 | Influenza Transport Swab Packages, Reference #20171, One lot with 1010 packa... | Quidel Corporation is recalling Influenza Transport Swab Packages because it may include an incor... | Class II | Quidel Corporation |
| Jan 23, 2017 | XTRAC Excimer Laser, Model No. AL8000, AL10000 The intended use is targete... | When the Liquid Guide ( LLG) is not used according to the operator manual, the switch control wir... | Class II | Strata Skin Sciences, Inc. |
| Jan 17, 2017 | Medtronic Strata II / Strata NSC Valves (includes Burr Hole and Lumbar Perito... | Medtronic Neurosurgery initiated a recall after receiving five (5) Product Experiences between Fe... | Class II | Medtronic Neurosurgery |
| Jan 9, 2017 | STERRAD NX Sterilization System, Product Code: 10033, 10033-002 | Advanced Sterilization Products (ASP) has identified that in a rare sequence of events following ... | Class II | Advanced Sterilization Products |
| Jan 6, 2017 | C2 CryoBalloon Ablation System - Controller Cap. C2 CryoBalloon Controller; ... | The Controller Cap of the C2 CyroBalloon Ablation System may crack as it is tightened onto the co... | Class II | C2 Therapeutics, Inc. |
| Jan 4, 2017 | AFX Endovascular AAA System Item Number Item Description F0070305 ... | Endologix updated information on the rates of Type III endoleaks and suggestions for patient surv... | Class II | Endologix |
| Jan 4, 2017 | AFX2 Endovascular AAA System Item No. Item Description F00820-01 BEA... | Endologix updated information on the rates of Type III endoleaks and suggestions for patient surv... | Class II | Endologix |
| Dec 27, 2016 | AFX Endovascular AAA System, Endoleak Type IIIB Common Name: AFX Bifurcate... | Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovas... | Class II | Endologix |
| Dec 27, 2016 | AFX Endovascular AAA System, Endoleak Type IIIB; The AFX Endovascular AAA Sy... | Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovas... | Class II | Endologix |
| Dec 27, 2016 | AFX Endovascular AAA System, Endoleak Type IIIA | Endologix initiated a correction by updating reports for the cumulative clinical data and informa... | Class II | Endologix |
| Dec 27, 2016 | AFX Endovascular AAA System, Endoleak Type IIIA Product Usage: The AFX En... | Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovas... | Class II | Endologix |
| Dec 27, 2016 | AFX Endovascular AAA System, Endoleak Type: IIIB Common Name: AFX Bifurcat... | Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovas... | Class II | Endologix |
| Dec 27, 2016 | AFX Endovascular AAA System, Endoleak Type IIIA Common Name: AFX Bifurcate... | Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovas... | Class II | Endologix |
| Dec 21, 2016 | AutoMate 2500 Family Catalog No. ODL25120 AutoMate 1200, ODL25125, AutoMate 1... | Beckman Coulter initiated a design change to update the Automate PC image to accommodate the oper... | Class III | Beckman Coulter Inc. |
| Dec 19, 2016 | UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465,... | Beckman Coulter has determined that additional clarification for the Blast Suspect messages is ne... | Class II | Beckman Coulter Inc. |
| Dec 19, 2016 | DxH 600 Coulter Cellular Analysis System, Catalog No. B23858 | Beckman Coulter has determined that additional clarification for the Blast Suspect messages is ne... | Class II | Beckman Coulter Inc. |
| Dec 12, 2016 | SwishTapered Implant | The extender product code (9037-03) that is packaged with the SwishTapered (Part Number 933308; L... | Class II | Implant Direct Sybron Manufacturing, LLC |
| Dec 6, 2016 | CyberKnife Robotic Radiosurgery Systems, models: G3, G4, VSI. Radiology: T... | Accuray has become aware of a potential safety issue involving the possibility of electric shock ... | Class II | Accuray Incorporated |
| Dec 2, 2016 | Alaris Pump Module, Model No. 8100 and AIL sensor kits, P/N 147083-102 and P/... | During an infusion, a false Air-in-Line (AIL) alarm would cause the infusion to be interrupted. | Class I | CareFusion 303, Inc. |
| Dec 2, 2016 | Eclipse Treatment Planning System version 13.MR2 [13.06.31 with Smart Segmen... | Modifications in version 13.6MR2 for Contouring, SmartAdapt, and SmartSegmentation workspaces res... | Class II | Varian Medical Systems, Inc. |
| Nov 30, 2016 | 133" 60 Drop 24 Hour Primary Set w/2 Bravo24¿, 2 Gang 1o2¿ Manifold, Rotating... | ICU Medical Inc. has identified an isolated event involving a 15 drop drip chamber assembled on a... | Class II | ICU Medical, Inc. |
| Nov 28, 2016 | GoDirect Screw-Retaining Top Part Numbers: 4500-61 | Consignees received product 6060-62, Replant Overdenture Abutment with the label for 4500-61 GoDi... | Class II | Implant Direct Sybron Manufacturing, LLC |
| Nov 23, 2016 | AQURE System Software Version 2.2.0 Model #: 933-599 UDI: (01)05700699335... | Design error when displaying additional information in the patient view window; error may result ... | Class II | Radiometer America Inc |
| Nov 22, 2016 | G3 Opticage Expandable Interbody Fusion Device, Model No. 9180-00, 9180-01, 9... | During implantation, the proximal end of the device could separate if the angle between the devic... | Class II | Interventional Spine Inc |
| Nov 22, 2016 | CyberKnife Robotic Radiosurgery System using software version 10.6; Catalog/... | Accuray has become aware of a potential safety issue involving unexpected treatment robot motion ... | Class II | Accuray Incorporated |
| Nov 21, 2016 | Ceramax Skin Barrier Cream: NET WT 0.1 OZ (3 g professional sample - not fo... | Firm became aware that professional samples of Ceramax are not meeting stability standards set fo... | Class II | Oculus Innovative Sciences, Inc. |
| Nov 20, 2016 | Shimadzu X-ray TV System, Catalog No. SONIALVISION G4 | Shimadzu Medical Systems is recalling Shimadzu X-ray TV System SONIALVISION due to possibility of... | Class II | Shimadzu Medical Systems |
| Nov 20, 2016 | Shimadzu X-ray High Voltage Generator Model No. UD150B-40 on SONIALVISION saf... | Shimadzu Medical Systems is recalling the Shimadzu X-ray High Voltage Generator due to the possib... | Class II | Shimadzu Medical Systems |
| Nov 17, 2016 | SmartSite Add-On Bag Access Device, Model No. 10013365 | CareFusion is recalling the SmartSite Add-On Bag Device due to reports of separation and/or leaka... | Class II | CareFusion 303, Inc. |
| Nov 15, 2016 | ImplantDirect Legacy 4 Implant, 5.7mmD x 5.7mmD Platform, Part 885708, Rx, St... | The vial cap was mislabeled with the incorrect part number of 855708 but the product description ... | Class II | Implant Direct Sybron Manufacturing, LLC |
| Nov 7, 2016 | Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing. | The device defect associated with this recall may result in HbA1c values with a negative bias in ... | Class II | Tosoh Bioscience, Inc. |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types, from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.